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A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction

Recruiting
18 - 70 years of age
Female
Phase 4

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Overview

The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

Description

This is a prospective, multi-surgeon, single blind, non-randomized, controlled trial with breasts allocated to two parallel groups: A mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride will be used on one side (Treatment side) as local infiltration, and plain 0.25% Bupivacaine Hydrochloride will be used in the control arm. Each breast will serve as the control for the other. The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively. These treatments are standard of care in clinical practice.

Eligibility

Inclusion Criteria

  • Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Exclusion Criteria

  • Inability to provide informed consent
  • Medical or surgical history precluding breast reduction
  • History of significant chronic pain requiring daily use of opioid or nonopioid analgesics
  • Pregnancy
  • Concomitant non-breast surgical procedure
  • Previous chest wall irradiation
  • Previous breast implant, breast reduction or breast lift surgery
  • Known allergy to bupivacaine or liposomal bupivacaine
  • Liver or kidney dysfunction
  • Use of antiplatelet or anticoagulation therapy.

Study details

Breast Reduction

NCT05891613

Mayo Clinic

30 March 2025

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